Cardiac rhythm management (CRM) devices are implanted in patients to provide various forms of electrical stimulation therapy. The number of such devices implanted into patients is generally increasing as a larger number of people are indicated for the therapy. However, the implantation of a medical device carries a risk of infection. As such, the increased rate of implantation results in more patients being placed at risk for infection. Some studies have indicated that patients have a 2-10% risk of infection after implant. The risk of infection is typically higher on revision procedures (device re-vision, change out, etc.) compared to de novo implants. The incidence of infection generally has a bi-modal distribution, where infections are most likely to occur either immediately after implant or several months after implant.
Infections carry a significant risk to the patient. Most infections begin at the pocket area where the device is implanted. If such infections spread to the stimulation leads and into the heart, complete CRM system explant and re-implant of a new device is usually required. Considerable risks are associated with explant, particularly lead extraction. In addition, these infections come at a tremendous cost to the healthcare system. Explant of a CRM system is very expensive and can include medical stays lasting several days until the infection has been cleared and a new device can be re-implanted.
It is difficult for clinicians caring for patients with implanted pacemakers or ICDs to detect infections. It is particularly difficult to detect infections at an early stage when non-surgical therapeutic intervention, such as the administration of anti-microbial active agents, would be most effective. For at least these reasons, a need exists for devices capable of detecting infections and related methods.